Fosun Pharma Subsidiary Henlius Receives NMPA Approval for Phase I Trial of Trispecific Antibody HLX3902

SHANGHAI — Shanghai Fosun Pharmaceutical (Group) Co., Ltd. announced Tuesday that its subsidiary Shanghai Henlius Biotech, Inc. has received approval from China's National Medical Products Administration to initiate a Phase I clinical trial for HLX3902 Injection.

The investigational drug is a trispecific antibody developed in-house by Henlius for the treatment of metastatic castration-resistant prostate cancer, or mCRPC, as well as other advanced solid tumors.

As of the announcement date on June 17, no similar trispecific antibody products have received marketing approval anywhere in the world, according to the company.

The regulatory green light marks a significant milestone for Henlius as it expands its oncology pipeline into next-generation antibody therapies. The Phase I trial will evaluate the safety, tolerability and preliminary efficacy of HLX3902 in patients with advanced malignancies.

Prostate cancer remains one of the most common cancers among men globally. Patients who develop metastatic castration-resistant disease face limited treatment options, creating substantial unmet medical demand for novel therapeutic approaches.

Trispecific antibodies represent an emerging class of immunotherapy designed to simultaneously engage multiple targets on cancer cells and immune system components, potentially offering enhanced therapeutic effects compared to conventional monoclonal or bispecific antibodies.

Henlius, listed on the Hong Kong Stock Exchange, is a biopharmaceutical company focused on the research, development, manufacturing and commercialization of innovative antibody therapies. The company has several products already approved and marketed in China and other markets.

Fosun Pharmaceutical, the Shanghai-based parent company, is one of China's largest healthcare conglomerates with businesses spanning pharmaceuticals, medical devices, diagnostics and healthcare services.